Effect of Low Doses of Hypoxia-inducible Factor- Prolyl Hydroxylase Enzyme Inhibitor Plus Iron in the Treatment of Anemia in Dialysis-dependent Chronic Kidney Disease Patients

NCT06115421 | Unknown Phase 4

• 1 other identifier: 0201793
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

this study aims to :

1. 1.To compare the efficacy of combining low doses of Roxadustat Hypoxia-Inducible Factor (HIF)-Prolyl Hydroxylase (PHD) inhibitor and iron versus standard treatment with erythropoietin-stimulating agents (ESA) in the treatment of anemia as a complication of chronic kidney disease (CKD) among dialysis-dependent patients.
2. 2.To emphasize the safety profile of low doses of Roxadustat HIF-PHD.
3. 3.To assess changes in the quality of life of patients with kidney disease before and after treatment.

Conditions

Anemia in Dialysis-dependent CKD Patients

Keywords

Dialysis-dependent CKD patients ,anemia ,hypoxia-inducible factor-; Roxadustatse

Outcome Measures

Primary Outcomes (3)

• Changes in hemoglobin level from baseline

  HB g/dl

  3 months

• Iron metabolism parameters change from the baseline

  serum iron µg/ml , ferritin µg/l, Total Iron Binding Capacity µg/ml (TIBC) levels, and transferrin saturation (TSAT)%

  3 months

• Safety profile

  adverse events will be reported using a pre-prepared checklist

  3 months

Secondary Outcomes (5)

• Time to achieve and maintain HB target

  3 months

• The need for rescue therapy

  3 months

• The minimum effective dose in combination with iron is needed to achieve the HB target.

  3 months

• Change in hepcidin level in the intervention group

  3 months

• Change in the Quality of Life (QoL) of the patients after the completion of the study period

  3 months

Study Arms (2)

oral low doses of Roxadustat three times weekly plus iron supplement,

EXPERIMENTAL

Drug: Roxadustat

Erythropoiesis-stimulating agents (ESAs)

ACTIVE COMPARATOR

Drug: Roxadustat

Interventions

Roxadustat DRUG

hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHIs)

Also known as: hypoxia-inducible factor- prolyl hydroxylase enzyme inhibitor

Erythropoiesis-stimulating agents (ESAs); oral low doses of Roxadustat three times weekly plus iron supplement,

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1. Ages \>18. 2. End Stage Renal Disease (ESRD) on Incident Dialysis (ID), defined as dialysis ≥2 weeks but ≤4 months or stable dialysis (dialysis dependent DD) defined as dialysis for ≥ 4 months \&having hemodialysis access.
• \. Hb ≤10.5 g/dl during the screening period. 4. Erythropoiesis-stimulating agents (ESAs) naïve patients, ESAs resistant patients, or patients who didn't receive any ESA treatment within 4-6 weeks

You may not qualify if:

• \. Age \<18 year or \>80 year 2. Known hypersensitivity to active substances, peanuts, soya, or any of the drug excipients.
• \. History of hereditary problems galactose intolerance 4. Systolic BP ≥160 mmHg or diastolic BP ≥95 mmHg, within 2 weeks prior to randomization. Patients may be reevaluated once BP is controlled.
• \. Congestive heart failure (CHF), New York Heart Association (NYHA) Class III or IV 6. Acute coronary syndrome (ACS), a thrombotic/thromboembolic event (eg, deep vein thrombosis (DVT) or pulmonary embolism (PE)), stroke, or seizure, within 12 weeks prior to randomization.
• \. Elective coronary revascularization or elective surgery that is expected to lead to significant blood loss.
• \. Hematologic diseases such as thalassemia, sickle cell anemia, active inflammatory bowel disease, active or chronic gastrointestinal bleeding, significant blood loss, or any other known causes for anemia other than CKD.
• \. Red blood cell transfusion within 6 weeks prior to the first screening visit.
• \. More than one dose of IV iron was received within 12 weeks prior to recruiting.
• \. History of uncontrolled chronic, severe, fulminant, autoimmune, or end-stage liver disease with Aspartate aminotransferase( AST), alanine aminotransferase (ALT) \> 3 × upper limit normal (ULN), or total bilirubin \> 1.5 × ULN. 12. Any clinically significant inflammatory disorders other than CKD, as any evidence of an active underlying infection, rheumatoid arthritis, systemic lupus, or cancer.
• \. Known and untreated retinal vein occlusion or proliferative diabetic retinopathy, macular degeneration, diabetic macular edema.
• \. Prior organ transplant or a scheduled organ transplantation date. 15. Planning for pregnancy, pregnant, or breastfeeding female patients

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, Egypt

RECRUITING

MeSH Terms

Interventions

roxadustat

Central Study Contacts

Effat F Hassan, MSc

CONTACT

01289678792; effatfarouk94@gmail.com

Noha A Hamdy, PhD

CONTACT

01005182151; nohaalaaeldine@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two-arm open-label non randomized active control study

Study Record Dates

• First Submitted: October 15, 2023
• First Posted: November 3, 2023
• Study Start: May 24, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 1, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)